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(DAN-uh-ZOLE)
Danocrine, Cyclomen
Class: Hormone

 Action Suppresses pituitary-ovarian axis by inhibiting output of pituitary gonadotropins; has weak, does-related androgenic activity with no estrogenic or progestational activity.

 Indications Treatment of endometriosis; symptomatic treatment of fibrocystic breast disease; prevention of attacks of hereditary angioedema. Unlabeled use(s): Treatment of precocious puberty, gynecomastia and menorrhagia; treatment of idiopathic immune thrombocytopenia, lupus-associated thrombocytopenia and autoimmune hemolytic anemia.

 Contraindications Pregnancy; lactation; undiagnosed abnormal genital bleeding; markedly impaired hepatic, renal or cardiac function.

 Route/Dosage

Endometriosis

ADULTS PO 800 mg/day in 2 divided doses.

Fibrocystic Breast Disease

ADULTS PO 100 to 400 mg/day in 2 divided doses.

Hereditary Angioedema

ADULTS PO 200 mg bid to tid.

 Interactions

Anticoagulants: May increase anticoagulant effects. Carbamazepine: May increase carbamazepine concentration. Cyclosporine: May increase cyclosporine levels, thus increasing risk of nephrotoxicity. Insulin: Diabetic patients may need increased insulin doses.

 Lab Test Interferences May interfere with tests for determination of testosterone, androstenedione and dehydroepiandrosterone levels.

 Adverse Reactions

DERM: Acne; mild hirsutism; oily skin or hair. GI: Gastroenteritis. HEPA: Jaundice; elevated liver function test results; hepatic dysfunction. OTHER: Edema; decreased breast size; deepening of voice; weight gain; flushing; sweating; vaginitis; nervousness; emotional lability; amenorrhea; anovulation; breakthrough bleeding.

 Precautions

Pregnancy: Category X. Advise patient that this medication must not be taken during pregnancy or when pregnancy is possible. Instruct patient to use reliable form of birth control when taking this medication. Lactation: Drug contraindicated in nursing women. Androgenic effects: May not be reversible even when drug is discontinued. Carcinoma of breast: Should be excluded before treatment of fibrocystic breast disease. Fluid retention: Carefully observe patients who cannot tolerate edema (eg, epilepsy, cardiac/renal dysfunction, migraine). Hepatic dysfunction: May occur; observe patient, monitor liver function tests periodically. Long-term experience: Limited. Similar drugs have been associated with serious toxicity (eg, cholestatic jaundice, peliosis hepatitis). Use lowest effective dose and consider decreasing dose or withdrawing therapy periodically.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Initiate therapy during menstruation or after negative pregnancy test result.
  • Give medication with food or milk to minimize GI irritation.
  • When treating endometriosis, dosage should be titrated down to lowest dose sufficient to maintain amenorrhea and therapeutic response.
  • Store drug in closed, light-resistant container at room temperature.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies.
  • Review pregnancy test results to be certain that pregnancy has been ruled out before starting drug therapy.
  • CBC and serum electrolytes should be performed before drug therapy is initiated.
  • Monitor patient closely for masculinizing effects and changes in sexuality pattern.
  • Monitor patient for signs of liver dysfunction (eg, liver function test changes, jaundice, nausea, vomiting, dark amber urine).
  • Monitor patient’s mental status: affect, mood, behavioral changes, aggression, sleep disturbances, depression.
  • Semen should be checked for volume, viscosity, sperm count and motility q 3 to 4 mo.
  • Perform ongoing assessment of patient’s fluid balance (I&O, daily weight). Note edema or weight gain > 2 lb/wk. Report findings to physician.
  • Observe for signs of hypercalcemia: GI symptoms, polydipsia, polyuria, increased calcium levels, decreased muscle tone.

 Patient/Family Education

  • Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
  • Remind patient to take medication with food or milk to minimize GI upset.
  • Instruct patient to notify physician if masculinizing effects occur (eg, abnormal facial hair or other fine body hair growth, deepening of voice, acne, clitoral enlargement, testicular atrophy, decrease in breast size). Inform patient that most of these side effects will cease after drug is discontinued; however, some changes may be irreversible (eg, permanent voice changes have occurred due to structural changes in larynx).
  • Inform patient to notify physician if change in libido should occur because this may indicate toxicity.
  • Instruct patient to eat low-sodium diet to prevent fluid retention and to notify physician of any signs of edema.
  • Advise women being treated for fibrocystic breast disease to notify physician of any nodule that persists or enlarges during treatment. Review proper technique for breast self-examination.
  • Caution patient not to discontinue drug abruptly.
  • Advise patient to notify physician of irregular menses. Explain that amenorrhea usually occurs but that menstruation usually resumes 2 to 3 mo after termination of therapy.
  • Explain that drug-induced anovulation is reversible within 2 to 3 mo of discontinuation of therapy.

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